Maximum residue limit opinions

This page lists the opinions of the Committee for Medicinal Products for Veterinary Use (CVMP) on maximum residue limit (MRL) evaluations.

The MRL is the maximum concentration of residue accepted by the European Union (EU) in a food product obtained from an animal that has received a veterinary medicine. The assessment of the safety of residues is carried out by the CVMP.

Any MRL opinion issued by the CVMP is published in the first instance as a summary of opinion, in line with the Agency's strategy to improve transparency in the regulatory process. The full opinion is published following the publication of the Commission Regulation formally establishing the MRL status and includes the European public MRL assessment report (EPMAR), which provides more detailed information on the scientific evaluation.

CVMP opinions on MRL evaluations are only published for substances evaluated after the entry into force of Regulation (EC) No 470/2009 on 6 July 2009. For all other substances, the EPMARs (formerly called summary reports) are available.

Opinions

Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide

Reference Number: EMA/CVMP/152100/2023

Opinion of the CVMP on the establishment of maximum residue limits: Toltrazuril

Reference Number: EMA/CVMP/683921/2021

Opinion of the CVMP on the establishment of maximum residue limits: Praziquantel

Reference Number: EMA/484831/2023

Opinion of the CVMP on the establishment of maximum residue limits : Bambermycin (EXTN/0002)

AdoptedReference Number: EMA/CVMP/371780/2021

Opinion of the CVMP on the establishment of maximum residue limits: Paromomycin

AdoptedReference Number: EMA/CVMP/56181/2018

Opinion of the CVMP on the establishment of maximum residue limits: Bupivacaine

AdoptedReference Number: EMA/CVMP/70565/2020

Opinion of the CVMP on the establishment of maximum residue limits : Imidacloprid

AdoptedReference Number: EMA/CVMP/446874/2020

Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (porcine)

AdoptedReference Number: EMA/CVMP/358731/2020

Opinion of the CVMP on the establishment of maximum residue limits: Bupivacaine

Reference Number: EMA/CVMP/278194/2020

Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine

Reference Number: EMA/94693/2021

Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen

Reference Number: EMA/CVMP/94867/2020

Opinion of the CVMP on the establishment of maximum residue limits: Ciclesonide

AdoptedReference Number: EMA/CVMP/101968/2019

Opinion of the CVMP on the establishment of maximum residue limits: Bambermycin

Reference Number: EMA/CVMP/202283/2019

Opinion of the CVMP on the establishment of maximum residue limits: Isoflurane

Reference Number: EMA/CVMP/103565/2018

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin

AdoptedReference Number: EMA/CVMP/698003/2017Summary:

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin

AdoptedReference Number: EMA/CVMP/698114/2017Summary:

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Opinion of the CVMP on the establishment of maximum residue limits: Fluazuron

AdoptedReference Number: EMA/CVMP/616458/2017

Divergent position on a CVMP opinion on the establishment of maximum residue limits: For extension of fluazuron for fin fish (automatic extrapolation to milk)

Adopted

Opinion of the CVMP on the establishment of maximum residue limits: Solvent naphtha, light aromatic

AdoptedReference Number: EMA/CVMP/617222/2017

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Alarelin

AdoptedReference Number: EMA/CVMP/185578/2017

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Bromelain

AdoptedReference Number: EMA/CVMP/255492/2017

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Fluralaner

AdoptedReference Number: EMA/CVMP/615777/2016

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Gamithromycin

AdoptedReference Number: EMA/CVMP/454065/2016

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Aluminium salicylate, basic

AdoptedReference Number: EMA/CVMP/453264/2016

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Monepantel

AdoptedReference Number: EMA/CVMP/322539/2016

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Hydrocortisone aceponate

Adopted

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin

AdoptedReference Number: EMA/CVMP/779112/2015

Opinion of the CVMP on the establishment of maximum residue limits: Copper carbonate

AdoptedReference Number: EMA/CVMP/758984/2015

Opinion of the Committee for CVMP on the establishment of maximum residue limits: Rafoxanide

AdoptedReference Number: EMA/CVMP/705308/2015

Opinion of the CVMP on the establishment of maximum residue limits: Gentamicin

AdoptedReference Number: EMA/CVMP/619915/2015Summary:

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Procedure no: EMEA/V/MRL/003669/EXPL/0002

Name of the substance: Gentamicin (INN)

Opinion of the CVMP on the establishment of maximum residue limits: Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts)

AdoptedReference Number: EMA/CVMP/245930/2015

Divergent opinion on maximum residue limits of 'Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts)'

Opinion of the CVMP on the establishment of maximum residue limits: Sisapronil

AdoptedReference Number: EMA/CVMP/259372/2015

Opinion of the CVMP on the establishment of maximum residue limits: Diethylene glycol monoethyl ether

AdoptedReference Number: EMA/CVMP/36684/2015

Opinion of the CVMP on the establishment of maximum residue limits: Aluminium salicylate, basic

AdoptedReference Number: EMA/CVMP/587830/2014

Opinion of the CVMP on the establishment of maximum residue limits: Clodronic acid

AdoptedReference Number: EMA/CVMP/239251/2014

Opinion of the CVMP on the establishment of maximum residue limits: Hexaflumuron

AdoptedReference Number: EMA/CVMP/347690/2014

Opinion of the CVMP on the establishment of maximum residue limits: Propyl 4-hydroxybenzoate and its sodium salt

AdoptedReference Number: EMA/CVMP/633015/2014

Opinion of the CVMP on the establishment of maximum residue limits: Tylvalosin

AdoptedReference Number: EMA/CVMP/380629/2014

Opinion of the CVMP on the establishment of maximum residue limits: Virginiamycin

AdoptedReference Number: EMA/CVMP/643808/2014

Opinion of the CVMP on the establishment of maximum residue limits: Barium selenate

AdoptedReference Number: EMA/CVMP/176966/2014

Opinion of the CVMP on the establishment of maximum residue limits: Potassium selenate, sodium selenate, sodium selenite

AdoptedReference Number: EMA/CVMP/666932/2014

Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin (modification of ADI and MRL)

AdoptedReference Number: EMA/CVMP/380415/2014

Opinion of the CVMP on the establishment of maximum residue limits: Doxycycline

AdoptedReference Number: EMA/CVMP/347869/2014Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Industria Italiana Integratori TREI spA submitted to the European Medicines Agency on 4 September 2013 an application for the extension of maximum residue limits for doxycycline to rabbits.

Opinion of the CVMP on the establishment of maximum residue limits: Gamithromycin

AdoptedReference Number: EMA/CVMP/350420/2014Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Merial submitted to the European Medicines Agency on 9 July 2013 an application for the extension of maximum residue limits for gamithromycin to porcine species.

Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone

AdoptedReference Number: EMA/CVMP/339063/2014Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Zoetis Belgium SA submitted to the European Medicines Agency on 22 January 2014 an application for the extension of maximum residue limits for methylprednisolone to Equidae.

Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin

AdoptedReference Number: EMA/CVMP/303753/2014Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Zoetis Belgium SA submitted to the European Medicines Agency on 26 April 2013 an application for the extension of maximum residue limits for tulathromycin to ovine species.

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin

AdoptedReference Number: EMA/CVMP/293995/2014Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Merial submitted to the European Medicines Agency on 30 April 2010 an application for the extension of maximum residue limits for eprinomectin to ovine species.

Opinion of the CVMP on the establishment of maximum residue limits: Lasalocid

AdoptedReference Number: EMA/CVMP/154734/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Pfizer Animal Health SA submitted to the European Medicines Agency on 23 October 2012 an application for the modification of maximum residue limits for lasalocid in poultry.

Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin

AdoptedReference Number: EMA/CVMP/604655/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Pfizer Animal Health SA submitted to the European Medicines Agency on 2 February 2012 an application for the modification of the ADI and maximum residue limits for tulathromycin in bovine and porcine species. The company subsequently changed the name to Zoetis Belgium SA.

Opinion of the CVMP on the establishment of maximum residue limits: Lufenuron

AdoptedReference Number: EMA/CVMP/651823/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Novartis Animal Health Inc (Switzerland) submitted to the European Medicines Agency on 6 March 2013 an application for the establishment of maximum residue limits for lufenuron in Atlantic salmon and Rainbow trout.

Opinion of the CVMP on the establishment of maximum residue limits: Cabergoline

AdoptedReference Number: EMA/CVMP/660284/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, CEVA Santà© Animale submitted to the European Medicines Agency on 21 September 2012 an application for the establishment of maximum residue limits for cabergoline in bovine species.

Opinion of the CVMP on the establishment of maximum residue limits: Clorsulon

AdoptedReference Number: EMA/CVMP/741367/2013 Rev.1Summary:

Pursuant to Article 27(2) of Regulation (EC) No 470/2009 of 6 May 2009, Irish Medicines Board submitted to the European Medicines Agency on 19 August 2011 a request for an opinion on the extrapolation of maximum residue limits for clorsulon to bovine milk.

Opinion of the CVMP on the establishment of maximum residue limits: Closantel

AdoptedReference Number: EMA/CVMP/741512/2013 Rev.1Summary:

Pursuant to Article 27(2) of Regulation (EC) No 470/2009 of 6 May 2009, Irish Medicines Board submitted to the European Medicines Agency on 19 August 2011 a request for an opinion on the extrapolation of maximum residue limits for closantel to bovine and ovine milk.

Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide

AdoptedReference Number: EMA/CVMP/672931/2013Summary:

Pursuant to Article 27(2) of Regulation (EC) No 470/2009 of 6 May 2009, Irish Medicines Board submitted to the European Medicines Agency on 19 August 2011 an application for the extrapolation of maximum residue limits for rafoxanide in bovine and ovine milk.

Opinion of the CVMP on the establishment of maximum residue limits: Triclabendazole

AdoptedReference Number: EMA/CVMP/649894/2013 Rev.1Summary:

Pursuant to Article 27(2) of Regulation (EC) No 470/2009 of 6 May 2009, the Irish Medicines Board submitted to the European Medicines Agency on 19 August 2011 a request for an opinion on the extrapolation of maximum residue limits for triclabendazole to bovine and ovine milk.

Opinion of the CVMP on the establishment of maximum residue limits: Ivermectin

AdoptedReference Number: EMA/CVMP/497546/2013Summary:

Pursuant to Article 11 of Regulation (EC) No 470/2009 of 6 May 2009, the European Commission submitted to the European Medicines Agency on 15 December 2010 a request to issue a new opinion on the substance ivermectin including the possibility to establish a MRL for the tissue muscle.

Opinion of the CVMP on the establishment of maximum residue limits: Tildipirosin

AdoptedReference Number: EMA/CVMP/440151/2013

Opinion of the CVMP on the establishment of maximum residue limits: Triptorelin acetate

AdoptedReference Number: EMA/CVMP/383203/2013

Opinion of the CVMP on the establishment of maximum residue limits: Diclazuril

AdoptedReference Number: EMA/CVMP/13722/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Huvepharma NV submitted to the European Medicines Agency on 29 August 2012 an application for the establishment of maximum residue limits for diclazuril in rabbits.

Opinion of the CVMP on the establishment of maximum residue limits: Butafosfan

AdoptedReference Number: EMA/CVMP/250946/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Bayer Animal Health GmbH submitted to the European Medicines Agency on 19 December 2012 an application for the extension of maximum residue limits for butafosfan to porcine species.

Opinion of the CVMP on the establishment of maximum residue limits: Chloroform

AdoptedReference Number: EMA/CVMP/317099/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Merial submitted to the European Medicines Agency on 01 October 2012 an application for the establishment of maximum residue limits for chloroform in all ruminants and porcine species.

On 7 February 2013 the Committee for Medicinal Products for Veterinary Use adopted a list of questions to be addressed by the applicant. The response to the list of questions was submitted on 19 April 2013.

Opinion of the CVMP on the establishment of maximum residue limits: Manganese carbonate

AdoptedReference Number: EMA/CVMP/14468/2013Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Warburton Technology submitted to the European Medicines Agency on 3 February 2012 an application for the extension of maximum residue limits for manganese carbonate in bovine species to include parenteral use.

Final opinion of the CVMP on the establishment of maximum residue limits: Neomycin

AdoptedReference Number: EMA/CVMP/840899/2011 Final, Rev.1Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, MERIAL submitted to the European Medicines Agency on 1 September 2010 an application for the modification of maximum residue limits for neomycin in bovine species.

Opinion of the CVMP on the establishment of maximum residue limits: Monepantel

AdoptedReference Number: EMA/CVMP/219741/2012

Opinion of the CVMP on the establishment of maximum residue limits: Prednisolone

AdoptedReference Number: EMA/CVMP/382060/2012

Opinion of the CVMP on the establishment of maximum residue limits: Double-stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israe...

AdoptedReference Number: EMA/CVMP/594122/2012

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin

AdoptedReference Number: EMA/CVMP/205176/2012Summary:

The Committee, having considered the application and having evaluated the response to the list of questions, recommends by consensus the establishment of provisional maximum residue limits for eprinomectin in ovine and caprine species.

Opinion of the CVMP on the establishment of maximum residue limits: Diclazuril

AdoptedReference Number: EMA/CVMP/183880/2012

Opinion of the CVMP on the establishment of maximum residue limits: Monensin

AdoptedReference Number: EMA/CVMP/804330/2011- Rev.1

Opinion of the CVMP on the establishment of maximum residue limits: Fenbendazole

AdoptedReference Number: EMA/CVMP/845730/2011

Opinion of the CVMP on the establishment of maximum residue limits: Phoxim

AdoptedReference Number: EMA/CVMP/78444/2012

Opinion of the CVMP on the establishment of maximum residue limits: Sodium salicylate

AdoptedReference Number: EMA/CVMP/63588/2012

Opinion of the CVMP on the establishment of maximum residue limits: Azamethiphos

AdoptedReference Number: EMA/CVMP/149845/2011 – Rev.1

Opinion of the CVMP on the establishment of maximum residue limits: Clorsulon

AdoptedReference Number: EMA/CVMP/915840/2011

Opinion of the CVMP on the establishment of maximum residue limits: Pegylated bovine granulocyte colony stimulating factor

AdoptedReference Number: EMA/CVMP/293093/2011Summary:

Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, Eli Lilly and Company Limited submitted to the European Medicines Agency on 4 March 2010 an application for the establishment of maximum residue limits for pegylated bovine granulocyte colony stimulating factor in bovine species.

Opinion of the CVMP on the establishment of maximum residue limits: Nitroxinil

AdoptedReference Number: EMA/CVMP/848524/2011

Opinion of the CVMP on the establishment of maximum residue limits: Closantel

AdoptedReference Number: EMA/CVMP/846763/2011

Opinion of the CVMP on the establishment of maximum residue limits: Triclabendazole

AdoptedReference Number: EMA/CVMP/848821/2011Summary:

Pursuant to Article 27 of Regulation (EC) No 470/2009 of 6 May 2009, Ireland submitted to the European Medicines Agency on 19 August 2011 a request for an opinion on extrapolation of maximum residue limits for closantel to bovine and ovine milk.

Opinion of the CVMP on the establishment of maximum residue limits: Altrenogest

AdoptedReference Number: EMA/CVMP/687242/2011

Opinion of the CVMP on the establishment of maximum residue limits: Octenidine dihydrochloride

AdoptedReference Number: EMA/CVMP/61867/2011-Rev.1

Opinion of the CVMP on the establishment of maximum residue limits: Phenoxymethylpenicillin

AdoptedReference Number: EMA/CVMP/447493/2011

Opinion of the CVMP on the establishment of maximum residue limits: Monepantel

AdoptedReference Number: EMA/CVMP/165867/2011-Rev.1

Opinion of the CVMP on the establishment of maximum residue limits: Lasalocid

AdoptedReference Number: EMA/CVMP/754527/2010

Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone

AdoptedReference Number: EMA/CVMP/822069/2010-Rev.1

Opinion of the CVMP on the establishment of maximum residue limits: Isoeugenol

AdoptedReference Number: EMA/CVMP/518785/2010

Opinion of the CVMP on the establishment of maximum residue limits: Monepantel

AdoptedReference Number: EMA/CVMP/569128/2010

Opinion of the CVMP on the establishment of maximum residue limits: Sodium Salicylate

AdoptedReference Number: EMA/CVMP/13789/2010

Opinion of the CVMP on the establishment of maximum residue limits: Derquantel

AdoptedReference Number: EMA/CVMP/261782/2010

Opinion of the CVMP on the establishment of maximum residue limits: Tildipirosin

Adopted

Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone

Adopted

Opinion of the CVMP on the establishment of maximum residue limits: Valnemulin

Adopted